Biogen Idec and Novartis have been in an aggressive race to release the first pill for Multiple Sclerosis; a milestone that could realize a hugely appealing $6 billion annually. Today the patients commonly take interferon injections to treat the disease. The availability of a oral pill would make their lives much easier.
FDA rejects Novartis-Merck Serono NDA for Cladribine
Biogen Idec has seen its own struggles developing Tysabri this year – from consolidation pressures to bad cases of side-effects in patients involved in clinical trials. It doesn’t seem like Novartis and Merck Serono will have it easy either. Last week, the FDA decided to reject Merck Serono’s NDA (New Drug Application) for Cladribine, a strong contender for the first MS pill. Merck Serono had applied for Cladribine’s NDA back in the first week of October (see our post here).
The company has issued a press release recently stating that the FDA did not find the application “sufficiently complete” after a substantive review. Although no details have been provided regarding the exact reasons, the blogosphere is full of speculations. The companies will request a meeting with the FDA officials to uncover the reasons behind the rejection and file a re-application as soon as they can.
Two major Phase II type studies had been submitted as part of the NDA package, called CLARITY and ORACLE MS – both performed to assess the safety, tolerability and efficacy of the drug. Although the CLARITY study reported a few cases of malignancies in patients, the molecule could have been a strong contender as its treatment regimen was more convenient for patients.
Novartis and Merck Serono are also developing another MS pill called Fingolimod, which seems to follow a more aggressive treatment regimen. The companies will apply for its NDA this month in the US and Europe. As we reported back in October, Novartis’ two-year FREEDOMS FTY-720 study showed that once-daily oral fingolimod reduced the relapse rate by 54 percent for the 0.5 mg dose in patients with relapsed MS.
The race for the first MS pill is all about capturing higher revenues before competition catches up
The competition for getting the first MS pill out is getting intense by each month, quite obviously because of the $6 billion market. The first drug will have a great competitive advantage starting out since it can be priced quite high – thereby capturing higher revenues before pricing competition takes over. It is quite clear that both companies are pursuing this race aggressively – like most speculation suggests, trying to get to the finish too soon is causing more mistakes than expected.
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